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Triple drug combination of telmisartan, amlodipine and hydrochlorothiazide in the treatment of essential hypertension  [PDF]
Manish Maladkar, Vijay Kumar Verma, Keshav A. Narsikar, Rajan D. Walinjkar, W. R. Patil, N. J. S. Saggu, Suresh P. Kulkarni
Open Journal of Internal Medicine (OJIM) , 2012, DOI: 10.4236/ojim.2012.22014
Abstract: Background: Triple drug therapy comprising angiotensin receptor blocker (ARB), calcium channel blocker (CCB) and hydrochlorothiazide (HCT) effectively controls essential hypertension as evident from the literature. This study was undertaken to assess the efficacy and safety of triple combination compared to the dual drug therapy. Methodologies: A total of 220 male and female patients with essential hypertension were enrolled in the study. The patients were divided into two groups. Group A received a bilayer tablet of FDC of Telmisartan + Amlodipine + HCT and group B received FDC tablet of Telmisartan + HCT. Both the treatments were administered once daily for twelve weeks. The patients were asked to follow-up on week 1, 2, 4, 6, 8 and 10 for periodic efficacy and safety evaluations. Effect on systolic blood pressure (SBP), diastolic blood pressure (DBP) and quality of life (QOL) were recorded during the course of the trial. Results: Blood pressure reduction (BP) to the desired goals was observed with both the treatments. The SBP and DBP reductions were superior in triple combination therapy than double combination. Both treatments improved QOL of patients. Conclusion: Triple drug combination of telmisartan, amlodipine and HCT may serve a potential role in achieving desired BP goals, in patients with essential hypertension, which are otherwise poorly managed by either monotherapy or dual drug therapy.
Review of dutasteride/tamsulosin fixed-dose combination for the treatment of benign prostatic hyperplasia: efficacy, safety, and patient acceptability
Barkin J
Patient Preference and Adherence , 2011, DOI: http://dx.doi.org/10.2147/PPA.S14032
Abstract: f dutasteride/tamsulosin fixed-dose combination for the treatment of benign prostatic hyperplasia: efficacy, safety, and patient acceptability Review (4248) Total Article Views Authors: Barkin J Published Date October 2011 Volume 2011:5 Pages 483 - 490 DOI: http://dx.doi.org/10.2147/PPA.S14032 Jack Barkin Humber River Regional Hospital, Toronto, Canada and Department of Surgery, University of Toronto, Toronto, Ontario, Canada Abstract: Lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) will usually affect older men, of whom 50% over the age 60 years and almost 90% in their nineties will be bothered enough by their symptoms that they request some type of treatment. However, symptomatic bother may also affect men in their forties with a prevalence rate of almost 18%. The International Prostate Symptom Score (IPSS) has become the most widely used and best validated questionnaire to allow the patient to quantify the severity of his LUTS/BPH symptoms. This score has become the cornerstone in demonstrating the “rate of symptom response” for the patient who has been exposed to any type BPH management. Question 8 on the IPSS score is what is defined as the “Quality of Life” question or what is also termed the “Bothersome Index.” The score out of 6 as declared by the patient will reflect the degree of concern that the patient is feeling about his symptoms and the reduction of the score after treatment is a statement of their improved quality of life. There are 2 families of accepted medical therapy to treat the symptoms of BPH and potentially prevent the most worrisome long-term sequelae of progression of BPH: urinary retention or the need for surgery. When defining the impact of the main types of medical therapy, the alpha blockers have been termed the “openers” and the 5 alpha-reductase inhibitors are described as the “shrinkers.” Since they each offer a different mechanism of effect, the concept of combination therapy was raised and trialed many times over recent years. The final aspect of any medical therapy is the patient's satisfaction with the treatment and the side effects. In the CombAT (Combination of Avodart and Tamsulosin) trial a new assessment was developed and tested called the Patient's Perception of Study Medication (PPSM) which told the investigators if the patients, given free choice, would choose to take that combination of medication to treat their problem and stay on the medication.
Rationale for triple fixed-dose combination therapy with an angiotensin II receptor blocker, a calcium channel blocker, and a thiazide diuretic  [cached]
Volpe M,Tocci G
Vascular Health and Risk Management , 2012,
Abstract: Massimo Volpe,1,2 Giuliano Tocci21Division of Cardiology, Department of Clinical and Molecular Medicine, University of Rome, Sapienza, Sant'Andrea Hospital, Rome, 2IRCCS Neuromed, Pozzilli, ItalyAbstract: Hypertension is a growing global health problem, and is predicted to affect 1.56 billion people by 2025. Treatment remains suboptimal, with control of blood pressure achieved in only 20%–35% of patients, and the majority requiring two or more antihypertensive drugs to achieve recommended blood pressure goals. To improve blood pressure control, the European hypertension guidelines recommend that angiotensin II receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) are combined with calcium channel blockers (CCBs) and/or thiazide diuretics. The rationale for this strategy is based, in part, on their different effects on the renin-angiotensin system, which improves antihypertensive efficacy. Data from a large number of trials support the efficacy of ACEIs or ARBs in combination with CCBs and/or hydrochlorothiazide (HCTZ). Combining two different classes of antihypertensive drugs has an additive effect on lowering of blood pressure, and does not increase adverse events, with the ARBs showing a tolerability advantage over the ACEIs. Among the different ARBs, olmesartan medoxomil is available as a dual fixed-dose combination with either amlodipine or HCTZ, and the increased blood pressure-lowering efficacy of these two combinations is proven. Triple therapy is required in 15%–20% of treated uncontrolled hypertensive patients, with a renin-angiotensin system blocker, CCB, and thiazide diuretic considered to be a rational combination according to the European guidelines. Olmesartan, amlodipine, and HCTZ are available as a triple fixed-dose combination, and significant blood pressure reductions have been observed with this regimen compared with the possible dual combinations. The availability of these fixed-dose combinations should lead to improvement in blood pressure control and aid compliance with long-term therapy, optimizing the management of this chronic condition.Keywords: angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, triple therapy, hypertension
Rationale for triple fixed-dose combination therapy with an angiotensin II receptor blocker, a calcium channel blocker, and a thiazide diuretic
Volpe M, Tocci G
Vascular Health and Risk Management , 2012, DOI: http://dx.doi.org/10.2147/VHRM.S28359
Abstract: tionale for triple fixed-dose combination therapy with an angiotensin II receptor blocker, a calcium channel blocker, and a thiazide diuretic Original Research (2712) Total Article Views Authors: Volpe M, Tocci G Published Date June 2012 Volume 2012:8 Pages 371 - 380 DOI: http://dx.doi.org/10.2147/VHRM.S28359 Received: 18 November 2011 Accepted: 23 December 2011 Published: 11 June 2012 Massimo Volpe,1,2 Giuliano Tocci2 1Division of Cardiology, Department of Clinical and Molecular Medicine, University of Rome, Sapienza, Sant'Andrea Hospital, Rome, 2IRCCS Neuromed, Pozzilli, Italy Abstract: Hypertension is a growing global health problem, and is predicted to affect 1.56 billion people by 2025. Treatment remains suboptimal, with control of blood pressure achieved in only 20%–35% of patients, and the majority requiring two or more antihypertensive drugs to achieve recommended blood pressure goals. To improve blood pressure control, the European hypertension guidelines recommend that angiotensin II receptor blockers (ARBs) or angiotensin-converting enzyme inhibitors (ACEIs) are combined with calcium channel blockers (CCBs) and/or thiazide diuretics. The rationale for this strategy is based, in part, on their different effects on the renin-angiotensin system, which improves antihypertensive efficacy. Data from a large number of trials support the efficacy of ACEIs or ARBs in combination with CCBs and/or hydrochlorothiazide (HCTZ). Combining two different classes of antihypertensive drugs has an additive effect on lowering of blood pressure, and does not increase adverse events, with the ARBs showing a tolerability advantage over the ACEIs. Among the different ARBs, olmesartan medoxomil is available as a dual fixed-dose combination with either amlodipine or HCTZ, and the increased blood pressure-lowering efficacy of these two combinations is proven. Triple therapy is required in 15%–20% of treated uncontrolled hypertensive patients, with a renin-angiotensin system blocker, CCB, and thiazide diuretic considered to be a rational combination according to the European guidelines. Olmesartan, amlodipine, and HCTZ are available as a triple fixed-dose combination, and significant blood pressure reductions have been observed with this regimen compared with the possible dual combinations. The availability of these fixed-dose combinations should lead to improvement in blood pressure control and aid compliance with long-term therapy, optimizing the management of this chronic condition.
Additive triple DMARD combination therapy of a low dose of sulfhydryl compounds, sulfasalazine and methotrexate in the treatment of rheumatoid arthritis: a clinical trial.  [PDF]
Nishiya K,Hisakawa N,Tahara K,Matsumori A
Acta Medica Okayama , 1999,
Abstract: To evaluate the efficacy and safety of additive triple disease modifying anti-rheumatic drug (DMARD) combination therapy of a low dose of sulfhydryl compounds D-penicillamine, bucillamine or tiopronin , sulfasalazine (SSZ) and methotrexate (MTX) as a treatment for rheumatoid arthritis (RA) patients, we studied a total of 33 Japanese RA patients (6 males, 27 females). At 1 or 2 months after simultaneous administration of the 3 above-mentioned DMARDs was begun, significant improvements were seen in markers of joint inflammation, i.e., erythrocyte sedimentation rate and C-reactive protein in sera. At 6 months, clinical improvement judged by the physicians' overall assessment of joint symptoms and laboratory data was observed in 29 (88%) of the 33 RA patients. No marked effect was observed in the other 4 (12%) patients, however. We observed no significant adverse reaction to this therapy. This suggests that additive triple DMARD combination therapy of a low dose of sulfhydryl compounds, SSZ and MTX could be a useful drug therapy for the treatment of RA patients, even those who are refractory.
Candesartan cilexetil/hydrochlorothiazide combination treatment versus high-dose candesartan cilexetil monotherapy in patients with mild to moderate cardiovascular risk (CHILI Triple T)
Gerd B nner, Bernhard Landers, Peter Bramlage
Vascular Health and Risk Management , 2011, DOI: http://dx.doi.org/10.2147/VHRM.S17004
Abstract: ndesartan cilexetil/hydrochlorothiazide combination treatment versus high-dose candesartan cilexetil monotherapy in patients with mild to moderate cardiovascular risk (CHILI Triple T) Original Research (5447) Total Article Views Authors: Gerd B nner, Bernhard Landers, Peter Bramlage Published Date February 2011 Volume 2011:7 Pages 85 - 95 DOI: http://dx.doi.org/10.2147/VHRM.S17004 Gerd B nner1, Bernhard Landers2, Peter Bramlage3 1Park-Klinikum Bad Krozingen, Germany; 2Internal Medicine Practice, Diabetes Center, Mayen, Germany; 3Institute for Cardiovascular Pharmacology and Epidemiology, Mahlow, Germany Background: Candesartan cilexetil has been shown to effectively reduce blood pressure and cardiovascular risk. Whether it is advantageous to combine candesartan cilexetil with low-dose hydrochlorothiazide (HCTZ) or uptitrate it in cases of insufficient blood pressure control has not been fully investigated under routine clinical conditions. Methods: CHILI Triple T is a prospective, noninterventional, observational study. Patients with uncontrolled hypertension and added cardiovascular risk received a fixed-dose combination of candesartan cilexetil 16 mg and HCTZ 12.5 mg (combination therapy group) or high-dose monotherapy with candesartan cilexetil 32 mg (high-dose monotherapy group). Results: A total of 4600 patients with a mean age of 63.1 ± 11.0 years, of which 44.7% were female, was included. The combination therapy group had 3337 patients, and the high-dose monotherapy group 1263 patients. Patients in both treatment groups were comparable with respect to age and gender, but patients receiving high-dose monotherapy had a slightly higher mean systolic blood pressure, more prior revascularizations, renal insufficiency, diabetic nephropathy, peripheral artery disease, and a lower ankle brachial index. The use of combination therapy resulted in a blood pressure reduction of -28.5 ± 13.8/-14.2 ± 9.4 mm Hg (P < 0.001 vs 160.2 ± 13.3/94.5 ± 8.2 mm Hg at baseline). The use of high-dose monotherapy reduced blood pressure by -29.73 ± 15.3/-14.1 ± 9.6 mm Hg (P < 0.001 vs 162.4 ± 14.7/94.7 ± 8.7 mm Hg at baseline). Differences in subgroups of patients defined by age, gender, body mass index, dyslipidemia, waist circumference, smoking, prior cardiovascular event, glomerular filtration rate, and microalbuminuria were minor, although partially significant. Tolerability was excellent, with only 28 out of 3358 patients (0.8%) in the combination therapy group and 15 out of 1273 patients (1.2%) in the high-dose monotherapy group experiencing any adverse event, of which one in each group was considered to be serious (<0.1%). Conclusions: Both the fixed-dose combination of candesartan cilexetil 16 mg and HCTZ 12.5 mg and high-dose monotherapy with candesartan 32 mg were highly effective in lowering blood pressure in patients at increased cardiovascular risk. Tolerability was excellent. The choice of either strategy therefore largely depends on the principal aim: b
Candesartan cilexetil/hydrochlorothiazide combination treatment versus high-dose candesartan cilexetil monotherapy in patients with mild to moderate cardiovascular risk (CHILI Triple T)  [cached]
Gerd Bönner,Bernhard Landers,Peter Bramlage
Vascular Health and Risk Management , 2011,
Abstract: Gerd B nner1, Bernhard Landers2, Peter Bramlage31Park-Klinikum Bad Krozingen, Germany; 2Internal Medicine Practice, Diabetes Center, Mayen, Germany; 3Institute for Cardiovascular Pharmacology and Epidemiology, Mahlow, GermanyBackground: Candesartan cilexetil has been shown to effectively reduce blood pressure and cardiovascular risk. Whether it is advantageous to combine candesartan cilexetil with low-dose hydrochlorothiazide (HCTZ) or uptitrate it in cases of insufficient blood pressure control has not been fully investigated under routine clinical conditions.Methods: CHILI Triple T is a prospective, noninterventional, observational study. Patients with uncontrolled hypertension and added cardiovascular risk received a fixed-dose combination of candesartan cilexetil 16 mg and HCTZ 12.5 mg (combination therapy group) or high-dose monotherapy with candesartan cilexetil 32 mg (high-dose monotherapy group).Results: A total of 4600 patients with a mean age of 63.1 ± 11.0 years, of which 44.7% were female, was included. The combination therapy group had 3337 patients, and the high-dose monotherapy group 1263 patients. Patients in both treatment groups were comparable with respect to age and gender, but patients receiving high-dose monotherapy had a slightly higher mean systolic blood pressure, more prior revascularizations, renal insufficiency, diabetic nephropathy, peripheral artery disease, and a lower ankle brachial index. The use of combination therapy resulted in a blood pressure reduction of -28.5 ± 13.8/-14.2 ± 9.4 mm Hg (P < 0.001 vs 160.2 ± 13.3/94.5 ± 8.2 mm Hg at baseline). The use of high-dose monotherapy reduced blood pressure by -29.73 ± 15.3/-14.1 ± 9.6 mm Hg (P < 0.001 vs 162.4 ± 14.7/94.7 ± 8.7 mm Hg at baseline). Differences in subgroups of patients defined by age, gender, body mass index, dyslipidemia, waist circumference, smoking, prior cardiovascular event, glomerular filtration rate, and microalbuminuria were minor, although partially significant. Tolerability was excellent, with only 28 out of 3358 patients (0.8%) in the combination therapy group and 15 out of 1273 patients (1.2%) in the high-dose monotherapy group experiencing any adverse event, of which one in each group was considered to be serious (<0.1%).Conclusions: Both the fixed-dose combination of candesartan cilexetil 16 mg and HCTZ 12.5 mg and high-dose monotherapy with candesartan 32 mg were highly effective in lowering blood pressure in patients at increased cardiovascular risk. Tolerability was excellent. The choice of either strategy therefore largely depends on the prin
Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study
Sung-Hae Kim, Kyu-Hyung Ryu, Nam-Ho Lee, Jin-Ho Kang, Woo-Shik Kim, Sang-Weon Park, Hae-Young Lee, Jae-Joong Kim, Young-Keun Ahn, Soon-Yong Suh
BMC Research Notes , 2011, DOI: 10.1186/1756-0500-4-461
Abstract: In this multi-center, double-blind, randomized study, adult patients (n = 148) with stage 2 hypertension were randomized to amlodipine 5 mg/losartan 50 mg or amlodipine 5 mg. After 2 weeks, patients with systolic blood pressure (SBP) > 140 mmHg were titrated to amlodipine 10 mg/losartan 50 mg or amlodipine 10 mg. After 4 weeks of titration, hydrochlorothiazide 12.5 mg could be optionally added to both groups. The change from baseline in SBP was assessed after 6 weeks. The responder rate (defined as achieving SBP < 140 mmHg or DBP < 90 mmHg) was also assessed at 2, 6 and 8 weeks as secondary endpoints. Safety and tolerability were assessed through adverse event monitoring and laboratory testing. Baseline demographics and clinical characteristics were generally similar between treatment groups. Least-square mean reduction in SBP at 6 weeks (primary endpoint) was significantly greater in the combination group (36.5 mmHg vs. 31.6 mmHg; p = 0.0117). The responder rate in SBP (secondary endpoints) was significantly higher in the combination group at 2 weeks (52.1% vs. 33.3%; p = 0.0213) but not at 6 weeks (p = 0.0550) or 8 weeks (p = 0.0592). There was no significant difference between groups in the incidence of adverse events.These results demonstrate that combination amlodipine/losartan therapy provides an effective and generally well-tolerated first line therapy for reducing blood pressure in stage 2 hypertensive patients.ClinicalTrials.gov: NCT01127217Hypertension has been recognized as an important risk factor for cardiovascular disease and is a leading risk factor for mortality [1]. Each year, the diagnosis and treatment of hypertension is increasing. By the year 2025, the prevalence is predicted to increase by 60% to approximately 1.56 billion worldwide, highlighting the need for improvement in the management and prevention of hypertension [2]. Inadequate recognition of hypertension, poor compliance of patients taking multiple drugs, and the reluctance of physician
Triple combination therapy with amlodipine, valsartan, and hydrochlorothiazide vs dual combination therapy with amlodipine and hydrochlorothiazide for stage 2 hypertensive patients  [cached]
Maurizio Destro,Nora Crikelair,Joseph Yen
Vascular Health and Risk Management , 2010,
Abstract: Maurizio Destro1, Nora Crikelair2, Joseph Yen2, Robert Glazer 1Azienda Ospedaliera della Provincia di Pavia, Stradella (PV), Italy; 2Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USAObjective: This post hoc analysis evaluated the efficacy and safety of triple therapy with amlodipine/valsartan+hydrochlorothiazide (Aml/Val+HCTZ) vs dual therapy with Aml+HCTZ in stage 2 hypertensive patients.Methods: The analysis included patients from an eight-week, multicenter, double-blind study, randomized to Aml/Val 10/160 mg or Aml 10 mg groups, who received add-on HCTZ 12.5 mg at week 4 if mean sitting systolic blood pressure (msSBP) was >130 mmHg.Results: Of the patients receiving Aml/Val+HCTZ and Aml+HCTZ, 98% (N = 133/136) and 96% (N = 200/208) completed the study, respectively. Baseline characteristics were similar across groups (Caucasians, 80.2%; diabetics, 14.8%; age, 58.6 years [28.2% ≥ 65 years]; body mass index, 31 kg/m2; mean sitting blood pressure (msBP), 171.5/95.5 mmHg [18% msSBP ≥ 180 mmHg]). Aml/Val+HCTZ provided significantly greater msBP reductions from baseline to week 8 than Aml+HCTZ (30.5/13.8 vs 24.3/8.3 mmHg, P < 0.0001). The incremental msBP reduction (week 4 to 8) with HCTZ added to Aml/Val was greater than when added to Aml (6.9/3.5 vs 3.1/1.0 mmHg, P < 0.01). Treatments were well tolerated with similar overall incidence of adverse events (Aml/Val+HCTZ: 33.8%, Aml+HCTZ: 33.2%).Conclusion: Aml/Val+HCTZ provided significantly greater BP reductions than Aml+HCTZ in patients with stage 2 hypertension. Aml/Val+HCTZ triple therapy may be a suitable option for patients requiring more than two agents to reach target BP.Keywords: amlodipine, valsartan, stage 2 hypertension, HCTZ, triple therapy
A critical appraisal of the clinical effectiveness of a fixed combination of valsartan, amlodipine, and hydrochlorothiazide in achieving blood pressure goals  [cached]
Cheryl L Laffer,Fernando Elijovich
Integrated Blood Pressure Control , 2011,
Abstract: Cheryl L Laffer1, Fernando Elijovich21Section of Hypertension and Vascular Medicine, 2Division of General Internal Medicine, Department of Medicine, Texas A&M Health Sciences Center College of Medicine, Temple, TX USAAbstract: Recent guidelines for the treatment of hypertension have focused on the need for multiple medications to get most patients to goal blood pressure (BP). Two to three different classes of antihypertensive agents are frequently required, increasing the risk of poor compliance with therapy. Hence, the guidelines have recommended starting with combination therapy in patients with BP that is over 20 mm Hg systolic or 10 mm Hg diastolic above goal. The latest advance in treatment regimen has been the development of triple-therapy combinations of an angiotensin receptor blocker, amlodipine, and hydrochlorothiazide. We review the pathophysiologic rationale for such a combination and the efficacy, safety, and tolerability of the first triple therapy that has become available: valsartan + amlodipine + hydrochlorothiazide. Finally, we suggest that use of triple therapy could improve the accuracy of diagnosing resistant hypertension, an increasingly prevalent and severe condition, by enhancing adherence to treatment and weeding out patients with pseudoresistance. This would allow for implementation of expensive and invasive workup only in those truly resistant patients in whom it is justified.Keywords: combination therapy, compliance, hypertension control rates, resistant hypertension
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